Molecules to Medicine: Plan B: The Tradition of Politics at the FDA

Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

Two of the speakers at the recent FDA at a Crossroads meeting were formerly at the FDA; both left because of political pressures. Dr. David Ross, was an FDA reviewer for Ketek (an antibiotic). In a Congressional hearing, Dr. Ross testified that he had been pressured to soften his findings about liver toxicity due to the drug and threatened by FDA Commissioner von Eschenbach, who said, “If you don’t follow the team, if you don’t do what you’re supposed to do, the first time you’ll be spoken to, the second time you’ll be benched, and the third time, you’ll be traded,” according to Ross.

The other was Dr. Susan Wood, former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, who resigned from the FDA after Plan B’s approval was initially denied.

A brief history of the FDA commissioners and other key persons over the past 20 years illustrates politics at work in the FDA.

David Kessler (commissioner,1990–1997) took a great deal of heat for trying to have the FDA regulate tobacco products and for trying to gain approval for RU-486 (mifepristone).(He lost on both counts.) He was also notable for being appointed by President George H. W. Bush and retained by President Clinton.

An infamous nominee for chairing Bush’s FDA advisory panel on women’s health policy was Dr. W. David Hager, an obstetrician-gynecologist. He had helped prepare a “citizens’ petition” calling for the FDA to reverse its approval of RU-486. He was perhaps more widely known for his reported refusal to prescribe contraceptives to married women and as author of a book that “recommends specific Scripture readings and prayers for such ailments as headaches and premenstrual syndrome.” After the outcry of critics, he was not appointed chair of the advisory panel but did serve on it in 2002–2005, despite bipartisan opposition.

Mark McClellan (commissioner, 2002–2004) was an economist appointed by George W. Bush. McClellan reportedly had decided against approving Plan B for emergency contraception even before his staff completed its analysis.

Andrew C. von Eschenbach (commissioner, 2005–2009) had been the head of the National Cancer Institute before being appointed as FDA commissioner. He was also tied to the decision of the FDA to deny emergency contraceptives over-the-counter status, despite the recommendation of the FDA’s advisory group and its own staff members, as well as that of many medical organizations.17 The FDA had followed advisory committee recommendations in every other case in the past decade. He is also known for reportedly threatening FDA reviewers who disagreed with him. Von Eschenbach’s ideologic, rather than evidence- based, decisions were so egregious that on March 23, 2009, the U.S. District Court (Tummino v. Torti) ordered the FDA to reconsider its decision blocking access to Plan B. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. The court’s conclusions about the FDA’s behavior were damning.

As a result of the politicization, the FDA staff has reportedly become greatly demoralized, interfering with its ability to function and protect the public. FDA whistle-blowers have testified that the agency considers the drug companies its clients, and its decision-making furthers the interests of those clients.

Many experienced and valuable clinicians have left the agency, leaving a void. Equally importantly, the FDA has lost considerable respect and authority in the eyes of both the public and important members of Congress.

From 2001 to 2009, the most obvious politicization at the FDA was related to women’s health issues, and especially access to contraception.

In March 2009, President Obama issued a memorandum on scientific integrity. A further encouraging sign of change was the May 2009 appointment of two well-respected physicians to lead the FDA, Drs. Margaret Hamburg and Joshua Sharfstein. Dr. Sharfstein has since left. Dr. Hamburg, the opening speaker at the UCS conference, noted that it was imperative to build trust in FDA’s integrity, and that it is science-based. Dr. Hamburg concluded that “I agree with the Center [for Drug Evaluation and Research (CDER)] that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

Unfortunately, Dr. Hamburg—and all women—just had the rug pulled out from them by Sebelius’ overtly political, evidence-be-damned stance.

Even the conservative American Academy of Pediatrics urged approval of the morning-after pill for young teens, recognizing Plan B as being a safer alternative to abortions or unwanted pregnancies.

Plan B has the same hormone found in birth control pills, progestin, but in a larger dose. It works primarily by preventing ovulation. In contrast, mifepristone, or RU-486, is used to induce a medical abortion in a process similar to a miscarriage.

What were the arguments against Plan B this time? President Obama expressed his concern as a parent, that his daughters must not have access to such a medicine without adult guidance. His personal preferences are not “evidence-based science”. And he is deluding himself. We can guide our children, but we cannot control their behavior. My hope has been to educate my kids and offer them counsel knowing that, for better or worse, they will make many mistakes along the way. Prevention of pregnancy through ready access to contraceptives is far safer than an abortion or unwanted pregnancy. . .which may doom a teen to a lifetime of poverty and misery. There is a superb cartoon capturing the debate, Matt Davies,’ “Which of these responsibilities is a 15 year old too young to be handed?”—a screaming baby or Plan B pill.

The Plan B Decision has been characterized as “Sacrificing ‘Change We Can Believe In’ for Expediency?” “Only half of the nation’s teen moms ever earn a diploma; more than half go on welfare; and more than half of the families started by teens live in poverty.” The Ft. Wayne paper has it right stating, “Plan B politics ignore human toll.” I have never understood how many conservatives can demand censorship, restriction of contraceptives, and control of women’s bodies, all in the name of being “pro-life.” Fetal rights trump a woman’s…but then these people take no responsibility for the care, feeding, and education of these unwanted children. The sanctity of life ends at the womb. A life sentence is a huge price for a moment’s mistake.

Mechai Viravaidya

Even Thailand, which many US citizens likely would (erroneously) consider to be a third-world country, is more enlightened in some health-related ways. For example, Mechai Viravaidya, a former Thai senator and founder of the Population and Community Development Association (PDA), and enormously successful family planning NGO, made a brilliant educational campaign focused on reducing both the birthrate and the AIDS epidemic, by making sex education fun and promoting condoms to be as readily available as cabbages. He even has a restaurant and resort known as “Cabbages and Condoms.” It was a wonderful place to visit.

So why did Obama and Sebelius kill OTC Plan B—the first time that the Health and Human Services Commission has ever overruled the FDA? Only two reasons come to mind. The first is that Obama is overtly campaigning for the conservative vote. The second is similar, but a bit less overt—that OTC Plan B was sacrificed to take a firmer stance on having contraceptive coverage as part of all insurance plans.

About the Author:Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.